{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:46:06Z","timestamp":1786977966861,"version":"build-2736575974"},"reference-count":18,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"8","license":[{"start":{"date-parts":[[2021,5,6]],"date-time":"2021-05-06T00:00:00Z","timestamp":1620259200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Hepatol Commun"],"published-print":{"date-parts":[[2021,8]]},"abstract":"<jats:p>\n                    Obeticholic acid (OCA) is approved for the treatment of patients with primary biliary cholangitis (PBC) who are partial responders or intolerant to ursodeoxycholic acid. Reports of serious liver injury have raised concerns about its safety in cirrhosis. We investigated the effects of treatment with OCA on hepatic decompensation and liver\u2010related mortality or transplantation in a cohort with compensated PBC cirrhosis. This was a retrospective cohort study using national data of US veterans with PBC and cirrhosis. We performed a propensity score model using variables associated with OCA prescription to control for baseline risk of decompensation. New OCA users were matched to nonusers. We identified 509 subjects with compensated PBC cirrhosis. We developed a propensity score model using variables associated with OCA prescription; 21 OCA users were matched with 84 nonusers. Over 569 and 3,847 person\u2010months, respectively, of follow\u2010up, 5 (23.8%) OCA users and 22 (26.2%) OCA nonusers decompensated. The C\u2010statistic of the propensity score model was 0.87. On multivariable analysis, after adjusting for potential confounders, OCA use was associated with an increased risk of hepatic decompensation (adjusted hazard ratio, 3.9; 95% confidence interval, 1.33\u201011.57;\n                    <jats:italic toggle=\"yes\">P<\/jats:italic>\n                    \u00a0=\u00a00.01). There was no association between OCA use and liver\u2010related mortality or transplantation (adjusted hazard ratio, 1.35; 95% confidence interval, 0.35\u20105.21;\n                    <jats:italic toggle=\"yes\">P<\/jats:italic>\n                    \u00a0=\u00a00.66).\n                    <jats:italic toggle=\"yes\">Conclusion:<\/jats:italic>\n                    OCA use was associated with an increase in hepatic decompensation but not liver\u2010related mortality or transplantation in patients with compensated PBC cirrhosis. Additional studies are recommended to prospectively investigate these findings.\n                  <\/jats:p>","DOI":"10.1002\/hep4.1720","type":"journal-article","created":{"date-parts":[[2021,5,7]],"date-time":"2021-05-07T08:56:42Z","timestamp":1620377802000},"page":"1426-1436","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":47,"title":["Impact of Obeticholic acid Exposure on Decompensation and Mortality in Primary Biliary Cholangitis and Cirrhosis"],"prefix":"10.1097","volume":"5","author":[{"given":"Binu V.","family":"John","sequence":"first","affiliation":[{"name":"Division of Hepatology,Bruce W Carter VA Medical Center,Miami,FL,USA"},{"name":"Division of Digestive Health and Liver Diseases,University of Miami Miller School of Medicine,Miami,FL,USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaley","family":"Schwartz","sequence":"additional","affiliation":[{"name":"Division of Hepatology,Bruce W Carter VA Medical Center,Miami,FL,USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cynthia","family":"Levy","sequence":"additional","affiliation":[{"name":"Division of Digestive Health and Liver Diseases,University of Miami Miller School of Medicine,Miami,FL,USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bassam","family":"Dahman","sequence":"additional","affiliation":[{"name":"Department of Health Behavior and Policy,Virginia Commonwealth University,Richmond,VA,USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yangyang","family":"Deng","sequence":"additional","affiliation":[{"name":"Department of Health Behavior and Policy,Virginia Commonwealth University,Richmond,VA,USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Martin","sequence":"additional","affiliation":[{"name":"Division of Digestive Health and Liver Diseases,University of Miami Miller School of Medicine,Miami,FL,USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tamar H.","family":"Taddei","sequence":"additional","affiliation":[{"name":"Section of Digestive Diseases,Yale School of Medicine,New Haven,CT,USA"},{"name":"Division of Gastroenterology and Hepatology,VA Connecticut Healthcare System,West Haven,CT,USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David E.","family":"Kaplan","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology,University of Pennsylvania,Philadelphia,PA,USA"},{"name":"Division of Gastroenterology and Hepatology,Corporal Michael J. 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for patients with primary biliary cholangitis: 3\u2010year results of an international open\u2010label extension study","volume":"4","year":"2019","journal-title":"Lancet Gastroenterol Hepatol"},{"key":"hep41720-bib-0018-20241015","doi-asserted-by":"crossref","first-page":"2164","DOI":"10.1111\/jgh.14700","article-title":"Impact of farnesoid X receptor single nucleotide polymorphisms on hepatic decompensation and mortality in cirrhotic patients with portal hypertension","volume":"34","year":"2019","journal-title":"J Gastroenterol Hepatol"},{"key":"hep41720-bib-0019-20241015","first-page":"1","article-title":"Emerging roles of FGF signaling in hepatocellular carcinoma","volume":"5","year":"2016","journal-title":"Transl Cancer Res"}],"container-title":["Hepatology 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